Acid Reducer Plus Antacid

Description

Famotidine 10 mg, calcium carbonate 800 mg, and magnesium hydroxide 165 mg are combined in a chewable tablet formulation designed for the reduction of gastric acid and to provide antacid effects. Each tablet is formulated to deliver a synergistic effect, combining the properties of an acid reducer with those of an antacid. The tablets are presented in a cool mint flavor, enhancing palatability. The product is packaged in a container containing 50 chewable tablets.

Uses and Indications

This drug is indicated for the relief of heartburn associated with acid indigestion and sour stomach.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to chew 1 tablet completely before swallowing to relieve symptoms. It is important to note that the tablet should not be swallowed whole. The maximum recommended dosage is 2 chewable tablets within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing and administration guidance.

Contraindications

Use is contraindicated in patients who experience difficulty or pain when swallowing food, vomiting with blood, or the presence of bloody or black stools, as these may indicate a serious underlying condition requiring medical evaluation. Additionally, concurrent use with other acid-reducing medications is contraindicated due to the potential for increased risk of adverse effects.

Warnings and Precautions

Patients should be aware of the following warnings and precautions associated with the use of this medication.

Allergy Alert This medication should not be used by individuals who are allergic to famotidine or other acid reducers.

Contraindications The medication is contraindicated in patients experiencing difficulty or pain when swallowing food, vomiting with blood, or the presence of bloody or black stools, as these symptoms may indicate a serious underlying condition. Such patients should seek medical attention promptly. Additionally, this medication should not be used concurrently with other acid reducers.

Pre-Use Consultation Healthcare professionals should be consulted prior to use if the patient has experienced heartburn for more than three months, as this may suggest a more serious condition. Patients should also seek medical advice if they experience heartburn accompanied by lightheadedness, sweating, or dizziness; chest pain or shoulder pain with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; frequent wheezing, particularly in conjunction with heartburn; unexplained weight loss; nausea or vomiting; stomach pain; or if they have a history of kidney disease.

Drug Interactions Patients taking prescription medications should consult with their doctor or pharmacist before using this product, as antacids and acid reducers may interact with certain prescription drugs.

Monitoring and Discontinuation Patients are advised to discontinue use and consult a healthcare professional if heartburn persists or worsens, or if the medication is required for more than 14 days.

Emergency Situations In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and patients are advised to discontinue use and consult a healthcare professional if they experience any of the following symptoms: difficulty or pain when swallowing food, vomiting with blood, or the presence of bloody or black stools, as these may indicate a serious underlying condition.

Patients should also seek medical advice prior to using this medication if they have experienced heartburn for more than three months, as this may signal a more serious condition. Additional symptoms that warrant consultation include heartburn accompanied by lightheadedness, sweating, or dizziness; chest pain or shoulder pain with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; frequent wheezing, particularly in conjunction with heartburn; unexplained weight loss; nausea or vomiting; stomach pain; or a history of kidney disease.

Common adverse reactions may include persistent heartburn or worsening symptoms. Patients are advised to stop using the medication and consult a healthcare provider if their heartburn continues or worsens, or if they find it necessary to use the product for more than 14 days.

It is important to note that individuals with known allergies to famotidine or other acid reducers should not use this medication. Additionally, the use of this product in conjunction with other acid reducers is not recommended.

Drug Interactions

Antacids and acid-reducing agents may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of administration when these agents are used concurrently with other drugs.

For optimal therapeutic outcomes, patients should be instructed to separate the administration of antacids or acid reducers from other medications by at least two hours. This precaution helps to minimize the risk of altered drug absorption and ensures that the prescribed medications maintain their intended effectiveness.

Packaging & NDC

Below are the non-prescription pack sizes of Acid Reducer Plus Antacid (famotidine, calcium carbonate, magnesium hydroxide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents and adults aged 12 years and older, it is important to note that the tablet should not be swallowed whole; it must be chewed completely before swallowing to effectively relieve symptoms. The maximum recommended dosage for this age group is 2 chewable tablets within a 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations effectively. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise.

Management procedures should include a thorough evaluation of the patient's condition, monitoring vital signs, and providing supportive care as necessary. Depending on the specific circumstances of the overdose, additional treatment measures may be warranted.

It is essential for healthcare professionals to remain vigilant and proactive in the management of overdose cases to ensure optimal patient outcomes.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis; hepatic effects, including elevated liver enzymes; renal effects, notably acute interstitial nephritis; and cardiovascular effects, such as arrhythmias. Gastrointestinal effects, including pancreatitis, have also been reported, along with hematologic effects like thrombocytopenia. Central nervous system effects, including confusion and hallucinations, were noted, as well as skin reactions, such as Stevens-Johnson syndrome. Additional reactions reported include dizziness and fatigue.

It is important to note that these adverse reactions were reported during postmarketing surveillance and may not be directly related to the use of the product. The frequency of these events is not known. Healthcare professionals are encouraged to report any adverse events to the FDA.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients not to use the product if they experience difficulty or pain while swallowing food, vomiting with blood, or notice bloody or black stools, as these symptoms may indicate a serious underlying condition that requires medical evaluation.

Patients should be cautioned against using this product in conjunction with other acid reducers. They must be instructed to discontinue use and consult a doctor if their heartburn persists or worsens. Additionally, patients should be advised to stop using the product and seek medical advice if they find it necessary to take it for more than 14 days.

Healthcare providers should encourage patients to consult a doctor before using the product if they have experienced heartburn for over three months, as this may signal a more serious condition. Patients should also be informed to seek medical advice if they experience heartburn accompanied by lightheadedness, sweating, or dizziness, or if they have chest pain or shoulder pain along with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders.

Furthermore, patients should be advised to consult a doctor if they frequently experience chest pain, wheezing (especially in conjunction with heartburn), unexplained weight loss, nausea, vomiting, or stomach pain. Those with a history of kidney disease should also seek medical advice prior to use.

Lastly, healthcare providers should recommend that patients consult a doctor or pharmacist before using the product if they are currently taking any prescription medications, as antacids and acid reducers may interact with certain drugs.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a temperature range of 20-25˚C (68-77˚F) to maintain its efficacy. Additionally, it is essential to protect the product from moisture to prevent degradation. Proper adherence to these storage conditions will help ensure the product remains effective throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with specific instructions for different age groups. For adults and children aged 12 years and older, the tablet should not be swallowed whole; it must be chewed completely before swallowing, with a maximum of two chewable tablets allowed within a 24-hour period. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is also important for patients to read the directions and warnings provided on the bottle, as it contains essential information regarding the medication's use.

Drug Information (PDF)

This file contains official product information for Acid Reducer Plus Antacid, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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